Development and Evaluation of Corn Zein-Based Biodegradable Medicated Chewing Gum Incorporating Rosemary Oil

Abstract

This study aims to develop and evaluate a corn zein-based biodegradable medicated chewing gum (MCG) incorporating rosemary oil as an active pharmaceutical ingredient (API). The objective was to create an eco-friendly dosage form that provides controlled release, enhanced bioavailability, and antimicrobial benefits while maintaining mechanical stability. MCGs were formulated by the conventional melting method using a combination of natural polymer and excipients. The formulations were evaluated for uniformity of content, texture profile analysis, in vitro drug release, biodegradability, and antimicrobial activity. Corn zein provided a biodegradable matrix with desirable elasticity and chewability. Rosemary oil contributed significant antimicrobial and antioxidant properties. Results revealed that the optimized formulation achieved a sustained drug release profile up to 30 minutes following Higuchi kinetics, with a marked inhibitory effect on Staphylococcus aureus and Escherichia coli. The formulation demonstrated biodegradation within 14 days, highlighting its environmental compatibility. This innovative dosage form provides a promising platform for patient-friendly, sustainable oral drug delivery systems.

Keywords

Introduction

Table No: 1 TPA values for various corn zein formulations

Sr. no.	Hardness (g)	Adhesiveness (g.sec)	Springiness*	Cohesiveness	Gumminess#	Chewiness (g)	Resilience
MCG 1	7508.504	_	0.350	0.277	911.802	318.760	0.203
MCG 2	5438.175	-0.361	0.981	0.289	1570.615	1540.699	0.239
MCG 3	4255.812	-2.179	0.562	0.302	431.717	242.618	0.203
MCG 4	3296.750	-15.088	0.510	0.357	1520.881	775.351	0.288
MCG 5	1427.704	-6.350	0.978	0.399	2997.525	2930.165	0.391
MCG 6	1179.900	-10.296	0.683	0.259	305.733	208.742	0.148
MCG 7	1659.563	-14.929	0.591	0.291	482.376	284.868	0.156
MCG 8	2079.366	-36.376	0.964	0.383	1071.969	1033.684	0.229
MCG 9	2801.884	-22.167	5.946	0.771	1603.209	9533.370	0.649
MCG 10	959.803	-0.787	0.410	0.276	264.767	108.573	0.179

Figure 1:  Overlay for Formulation of MCG 1 – MCG 10

4.4 Compatibility Studies (FTIR, DSC, SEM)

Fourier-Transform Infrared Spectroscopy (FTIR) revealed no significant chemical interaction between rosemary oil and zein. Characteristic peaks corresponding to –OH and C=O groups remained intact, validating molecular stability. Differential Scanning Calorimetry (DSC) analysis displayed a single broad endothermic peak, indicating partial miscibility between polymer and drug, enhancing controlled release. Scanning Electron Microscopy (SEM) images demonstrated a homogenous, non-porous surface morphology with fine dispersion of oil droplets, which supports uniform diffusion through the zein matrix.

4.5 Biodegradation Analysis

Biodegradation studies were conducted in simulated saliva medium over 14 days. The gum base began showing visible softening by day 8 and complete disintegration by day 14. Weight loss studies revealed a 70% reduction in mass by the final day, confirming the biodegradable nature of the zein polymer. Such degradation is advantageous for environmental safety and post-use disposal.

Fig no: 2  MCG at start of biodegradation cycle in weathering chamber

Fig no: 3 MCG after 2500 hrs of biodegradation cycle in weathering chamber

4.6 Antimicrobial Evaluation

Antimicrobial assays demonstrated strong inhibitory zones against Staphylococcus aureus (14 mm) and Escherichia coli (12 mm). The presence of carnosic and rosmarinic acids within rosemary oil accounts for its bactericidal atcion    by disrupting cell membranes and inhibiting bacterial respiration. The results confirming rosemary oil’s efficacy in pharmaceutical dosage forms

Fig No: 4 Activity against S. aureus

Fig No: 5 Activity against E. coli

4.7 Comparative Assessment and Discussion

Comparative analysis with previous formulations such as caffeine-based gums (Aslani et al., 2013) indicates superior mechanical stability and longer sustained release. The integration of zein provides structural resilience under chewing stress, unlike synthetic bases that deform rapidly. Moreover, rosemary oil enhances therapeutic potential through antimicrobial and antioxidant actions, broadening applicability in oral hygiene and minor infection management. Overall, this study demonstrates the feasibility of integrating biodegradable biopolymers and essential oils for advanced oral delivery systems.

CONCLUSION

The development of corn zein-based biodegradable medicated chewing gum incorporating rosemary oil represents a significant advancement in oral controlled release technologies. The optimized formulation exhibited favorable physicochemical and mechanical properties, ensuring both patient compliance and dosage uniformity. The diffusion-controlled release behavior (Higuchi model) confirmed zein’s capacity to function as a sustainable polymer matrix for lipophilic actives.

This formulation fulfills multiple objectives — it enhances bioavailability via buccal absorption, promotes patient convenience, and minimizes gastrointestinal degradation. The inclusion of rosemary oil introduces antimicrobial and antioxidant functionality, offering preventive benefits against oral infections. The biodegradability of the zein base further aligns this research with global sustainability initiatives, reducing polymeric waste associated with synthetic gum matrices.

From a manufacturing perspective, the approach utilizes cost-effective, readily available materials and does not require complex instrumentation, making it feasible for large-scale production. The study also lays the groundwork for further investigations into other herbal actives and combinations for multifunctional oral therapeutics. In future, advanced analytical studies such as mucoadhesion testing, sensory analysis, and clinical evaluation could validate patient acceptance and therapeutic efficacy. This work contributes to a growing domain of natural, eco-friendly pharmaceutical innovations with potential industrial applicability.

ACKNOWLEDGEMENT

We would to give thanks to Sri Vijay Vidyalaya College of Pharmacy, Department of  Pharmaceutics, Nallampalli, Dharmapuri, Tamilnadu for providing laboratory facilities and necessary reagents during this study.  

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